Herbal medicinal products in the European Union - AESGP

Denmark
Finland
Greece
Ireland
Italy
Luxembourg
The Netherlands
Portugal
Sweden
United Kingdom
Table 16: Countries without the option to provide simplified proof of efficacy
Austria, Belgium, France, Germany and Spain have established a simplified proof of
efficacy in their marketing authorisation procedures. The following requirements exist for
quality documentation, proof of safety and proof of efficacy:
Country Quality Safety Efficacy
Austria Specified in list Considered as proven Reference to list
Belgium Specified in list (Ph.Eur.) Reference to list Reference to list
France Dossier to be submitted Cat. 1: no studies
Cat. 2: reduced
toxicity required
Reference to list
Germany Dossier to be submitted,
but only checked on a
random basis
Considered as proven Reference to list
Spain Dossier to be submitted Considered as proven Reference to list
Table 17: Requirements for quality documentation, proof of safety and proof of
efficacy in Member States
VII.2.8 Indication Claim of the Category with Simplified Proof of Efficacy
Member States were asked if a specific indication claim (introductory term) exists for
preparations included in the above-mentioned category – as far as this category exists –
which is authorised by a simplified marketing authorisation procedure.
Country No specific statement Specific statement
Austria x
Belgium x
France “Traditionally used in ...” (except laxatives)
Germany “Traditionally used in ...”
Spain x
Table 18: Specific indication claims for the simplified proof of efficacy
Notes:
1) Belgium:
The phrase “Traditionally used in…” was used up to 1994.
Other countries use a “traditional” term for specific groups of products whose marketing
authorisation procedure is different from the simplified proof of efficacy described in this
chapter:
2) Finland:
According to the legal definition, “herbal remedies” are products traditionally used for
medicinal purposes in which the active principle or principles is or are derived from the
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